QMSrs Work Instruction
Problem Management Work Instructions
This Document is the Work Instructions (WI) for
Problem Management
ID
QMSrs-011-E-PrM-WI
Title
QMSrs Problem Management Work Instructions
DCR ID
DCR-004
Issue No.
4
Date:
PAGE 2 of 17
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
2
Introduction .......................................................................... 3
Purpose
...................................................................................
3
Scope
.......................................................................................
3
Referenced Documents
...........................................................
3
Problem Management Process ............................................... 4
Problem Management Work Instruction ................................ 4
Approve problem
.....................................................................
4
Create a Problem
....................................................................
4
Create Problem Action
............................................................
8
Manage Problem actions
........................................................
9
Manage Problems
.................................................................
11
Problem Management settings
.............................................
12
Reports
..................................................................................
13
Quality Records and Archives ............................................... 16
ID
QMSrs-011-E-PrM-WI
Title
QMSrs Problem Management Work Instructions
DCR ID
DCR-004
Issue No.
4
Date:
PAGE 3 of 17
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
3
INTRODUCTION
This Document is the Work Instruction (WI) for Problem Management
PURPOSE
This WI defines the steps that are followed to add, update and monitor the problems
inside the organisation.
SCOPE
The WI applies to the QMSrs Tool set that accompanies this WI
REFERENCED DOCUMENTS
Doc. No.
Doc. Description
QMSrs-T-00-E
QMSRS Document Template
ID
QMSrs-011-E-PrM-WI
Title
QMSrs Problem Management Work Instructions
DCR ID
DCR-004
Issue No.
4
Date:
PAGE 4 of 17
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
4
PROBLEM MANAGEMENT PROCESS
This section displays the flow of the process.
PROBLEM MANAGEMENT WORK INSTRUCTION
APPROVE PROBLEM
This section explains how to approve a problem
To approve a problem:
Go to Problem Management section in the QMS.
Select ‘Approve Problem '.
Only problem records that need your approval will appear to you.
Click on edit icon“ “beside the problem record that you want to add
approval for (The status of the problem should be open).
Click on 'Approval Details' tab then select the status of the approval from the
drop down list and enter the justification.
Click on “Save “to save the amended data or “Cancel” to cancel the changes.
CREATE A PROBLEM
This section explains how to create a problem in the QMS.
To create a problem:
Go to Problem Management section in the QMS.
ID
QMSrs-011-E-PrM-WI
Title
QMSrs Problem Management Work Instructions
DCR ID
DCR-004
Issue No.
4
Date:
PAGE 5 of 17
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
5
Select ‘Create a Problem’.
Select the type of the Problem(Incident, Complaint,..) from the drop down list
or add new type by clicking on add icon' '
Enter the case number.
Fill the mandatory fields with the red asterisk ‘*’ and any other fields you
have data for.
Click on save icon “ ” to save changes that appears at the top of the
window.
Problem Entry Fields
Below are the fields to be completed when adding a Problem.
Field Name
Description
Main Information
Affected Party Type
Select the type of the affected party from the drop
down list
Affected Document
Click on search sign" " and select the type of the
document then select the affected document
Problem
Enter the Problem title
Problem Description
Enter the description of the problem
ID
QMSrs-011-E-PrM-WI
Title
QMSrs Problem Management Work Instructions
DCR ID
DCR-004
Issue No.
4
Date:
PAGE 6 of 17
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
6
Related Causes
Root Cause
Select the cause from the drop down list then click on
the title of the cause that appears on the left side of the
window , the fields will be filled automatically and the
user can change the name and the information of the
problem ,User can also add ' ' and delete' 'sub
root causes to the main root cause and edit them by the
same way that he used in the main cause (mentioned
above)
Additional Information
Problem Originator
Click on search sign" " then select the unit and the
employee from the drop down list
Problem Owner
Click on search sign" " then select the unit and the
employee from the drop down list
Problem Executive
Click on search sign" " then select the unit and the
employee from the drop down list
Raise Date
Select the raise date from the calendar
Origination Date
Select the origination date from the calendar
Target Close Date
Select the target close date from the calendar
Supplementary Information
Reported From
Select the unit that report the problem from the drop
down list
ID
QMSrs-011-E-PrM-WI
Title
QMSrs Problem Management Work Instructions
DCR ID
DCR-004
Issue No.
4
Date:
PAGE 7 of 17
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
7
ADDING APPROVAL MEMBERS
Go to Problem Management section in the QMS.
Select ‘Create a Problem’.
Click on Approval details tab then click on add icon“ “.
Double click on 'Member 'field and select the name from the drop down list.
Double click on 'Type' field and select the type from the drop down list.
Click on “Save “to save the amended data or “Cancel” to cancel the changes.
Source of Problem
Select the unit where the problem occurred from the
drop down list
Severity Criteria
Select the criteria from the drop down list
Select Risk Category
Select from the drop down list or add new one by
clicking on add icon ' '
Associated Risk List
Check the appropriate risk list that appears according to
risk category
Approval details
Approval Details
Look at "Adding Approval Members "section below
ID
QMSrs-011-E-PrM-WI
Title
QMSrs Problem Management Work Instructions
DCR ID
DCR-004
Issue No.
4
Date:
PAGE 8 of 17
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
8
* 'Approval Status' and 'Decision Details' fields will be filled later from Approve
Problem section by the member whom you add and responsible for the decision.
DELETING APPROVAL MEMBERS
Go to Problem Management section in the QMS.
Select ‘Create a Problem’.
Click on Approval details tab then click on delete icon “that is located
beside the member you want to delete.
Click on “Save “to save the amended data or “Cancel” to cancel the changes.
CREATE PROBLEM ACTION
This section explains how to create an action for a problem in the QMS.
To create an action for a problem:
Go to Problem Management section in the QMS.
Select ‘Create Problem Action’.
Click on search sign" " from the drop down list then select the problem that
you want to add action for.
Fill the mandatory fields with the red asterisk ‘*’ and any other fields you
have data for.
Click on save icon “ ” to save changes that appears at the top of the
window.
ID
QMSrs-011-E-PrM-WI
Title
QMSrs Problem Management Work Instructions
DCR ID
DCR-004
Issue No.
4
Date:
PAGE 9 of 17
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
9
Problem actions Entry Fields
Below are the fields to be completed when adding a Problem action.
MANAGE PROBLEM ACTIONS
In this section the user can edit, delete and use the filter to search actions using
varying criteria.
Field Name
Description
Problem Action Details
Action Title
Enter the title of the action
Action Type
Select the type of the action from the drop down list
Start Date
Select the start date from the calendar
Planned End Date
Select the planned end date from the calendar
Actionee
Click on search sign" " then select from the drop
down list
Description
Enter the description of the action
ID
QMSrs-011-E-PrM-WI
Title
QMSrs Problem Management Work Instructions
DCR ID
DCR-004
Issue No.
4
Date:
PAGE 10 of 17
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
10
EDIT AN ACTION
Go to Problem Management section in the QMS.
Select ‘Manage Problem Actions’.
Click on edit icon“ “beside the action that you want to edit (if the problem
is still open).
Make the necessary changes.
Click on “Save “to save the amended data or “Cancel” to cancel the changes.
DELETE AN ACTION
Go to Problem Management section in the QMS.
Select ‘Manage Problem Actions’.
Click on delete icon “ “beside the action that you want to delete.
To delete the action click on “OK “or “Cancel “to cancel deleting.
SEARCH AN ACTION
Go to Problem Management section in the QMS
Select ‘Manage Problem Actions’.
Click on filter icon “ “at the top of the window, then select the search
criteria.
ID
QMSrs-011-E-PrM-WI
Title
QMSrs Problem Management Work Instructions
DCR ID
DCR-004
Issue No.
4
Date:
PAGE 11 of 17
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
11
Fill the text field or select from the drop down list which depends on the
search criteria you choose.
MANAGE PROBLEMS
In this section the user can edit, delete and use the filter to search problems using
varying criteria.
EDIT A PROBLEM
Go to Problem Management section in the QMS.
Select ‘Manage Problems’.
Click on edit icon“ “beside the problem that you want to edit.
Make the necessary changes.
Click on “Save “to save the amended data or “Cancel” to cancel the changes.
DELETE A PROBLEM
Go to Problem Management section in the QMS.
Select ‘Manage Problems’.
Click on delete icon “ “beside the problem that you want to edit.
To delete the Problem click on “OK “or “Cancel “to cancel deleting.
ID
QMSrs-011-E-PrM-WI
Title
QMSrs Problem Management Work Instructions
DCR ID
DCR-004
Issue No.
4
Date:
PAGE 12 of 17
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
12
SEARCH A PROBLEM
Go to Problem Management section in the QMS
Select ‘Manage Problems’.
Click on filter icon “ “at the top of the window, then select the search
criteria.
Fill the text field or select from the drop down list which depends on the
search criteria you choose.
PROBLEM MANAGEMENT SETTINGS
In this section the user can add, edit and delete problems type.
PROBLEM TYPE
ADD A PROBLEM TYPE
Go to Problem Management section in the QMS.
From Problem Management Settings select ‘Problems Type’.
Click on create icon " “.
Enter the title of the problem type and its description.
Click on “Save “to save the amended data or “Cancel” to cancel the changes.
ID
QMSrs-011-E-PrM-WI
Title
QMSrs Problem Management Work Instructions
DCR ID
DCR-004
Issue No.
4
Date:
PAGE 13 of 17
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
13
EDIT A PROBLEM TYPE
Go to Problem Management section in the QMS.
From Problem Management Settings select ‘Problems Type’.
Click on edit icon“ “beside the type that you want to edit.
Make the necessary changes.
Click on “Save “to save the amended data or “Cancel” to cancel the changes.
DELETE A PROBLEM TYPE
Go to Problem Management section in the QMS.
From Problem Management Settings select ‘Problems Type’.
Click on delete icon “ “beside the type that you want to edit.
To delete the Type click on “OK “or “Cancel “to cancel deleting.
REPORTS
PROBLEM BREAKDOWN BY YEAR
ID
QMSrs-011-E-PrM-WI
Title
QMSrs Problem Management Work Instructions
DCR ID
DCR-004
Issue No.
4
Date:
PAGE 14 of 17
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
14
In this section user can view a chart for the number of problems per year.
In this dynamic report, the user can choose the fields that he wants to appear
in the chart by selecting from the drop down list of “display fields” that found
at the top of the page and then click on “ icon.
STATISTICS OF OPEN / CLOSED ACTIONS
In this section user can view a chart that analyze the problem actions
according to their status (open / closed)
In this dynamic report, the user can choose the fields that he wants to appear
in the chart by selecting from the drop down list of “display fields” that found
at the top of the page and then click on “ “ icon.
STATISTICS OF PROBLEMS GROUPED BY ROOT CAUSE
In this section user can view a chart that analyse the problem according to
their root cause.
In this dynamic report, the user can choose the fields that he wants to appear
in the chart by selecting from the drop down list of “display fields” that found
at the top of the page and then click on “ “ icon.
STATISTICS OF PROBLEMS GROUPED BY SEVERITY
In this section user can view a chart of the problems according to their
Severity.
ID
QMSrs-011-E-PrM-WI
Title
QMSrs Problem Management Work Instructions
DCR ID
DCR-004
Issue No.
4
Date:
PAGE 15 of 17
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
15
In this dynamic report, the user can choose the fields that he wants to appear
in the chart by selecting from the drop down list of “display fields” that found
at the top of the page and then click on “ icon.
STATISTICS OF PROBLEMS GROUPED BY STATUS
In this section user can view a chart of the problems according to their status.
In this dynamic report, the user can choose the fields that he wants to appear
in the chart by selecting from the drop down list of “display fields” that found
at the top of the page and then click on “ icon.
VIEW PROBLEM ACTIONS
In this section user can displays all the problems actions with their status.
Different filter criteria can be used (Type, status, Actionee, originator,
owner…).
User can export the problem actions report.
Click on export icon" "to export the data into different format (Xls.
PDF...)
In this dynamic report, the user can choose the fields that he wants to
appear in the table by selecting from the drop down list of “display fields”
that found at the top of the page and then click on “ “ icon.
You can use varying criteria as follows:
Click on filter icon “ “at the top of the window, then choose the search
criteria you want.
Select from the drop down list and click on next icon" ".
ID
QMSrs-011-E-PrM-WI
Title
QMSrs Problem Management Work Instructions
DCR ID
DCR-004
Issue No.
4
Date:
PAGE 16 of 17
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
16
To clear the result of filtration click on delete Filter icon" ".
VIEW PROBLEMS
In this section user can displays all the problems with their status. Different
filter criteria can be used (Type, status, Actionee, Root Cause, Record Mode…).
User can export the problems report.
Click on export icon" "to export the data into different format (Xls.
PDF...)
In this dynamic report, the user can choose the fields that he wants to
appear in the table by selecting from the drop down list of “display fields”
that found at the top of the page and then click on “ “ icon.
You can use varying criteria as follows:
Click on filter icon “ “at the top of the window, then choose the search
criteria you want.
Select from the drop down list and click on next icon" ".
To clear the result of filtration click on delete Filter icon" ".
QUALITY RECORDS AND ARCHIVES
Reference
Record Description
Location
Retention
QMSrs Tool
Quality Records
http://www.qmsrs.org
5 Years
ID
QMSrs-011-E-PrM-WI
Title
QMSrs Problem Management Work Instructions
DCR ID
DCR-004
Issue No.
4
Date:
PAGE 17 of 17
© 2017 QMS Resourcing Services Ltd Confidential Uncontrolled in Print
17